Globally harmonized Anatomic Pathology in-house services
We offer a quality management system that delivers high quality, dependable data for your study. All clinical laboratories across our regions ensure a globally harmonized SOP process that minimizes technical variability in your study. Our expert pathologists, histotechnologists, clinical, and laboratory staff are trained in good documentation practices, with each AP lab containing on-site experts with >20 years’ experience.
In each of our labs, we have a goal of at least 98% achievement of turnaround time (TAT) for each study. Our Anatomic Pathology laboratories also participate in an accuracy-driven external quality assurance program (CAP Proficiency Testing) that supports our goal of achieving global harmonization, standardization and high quality results across the globe for every study.
Anatomic Pathology for biomarker development in oncology clinical trials – We can provide customized, global laboratory anatomic pathology lab solutions specifically suited for the unique combinations of therapeutic indication and targeted mechanism-of-action driving modern oncology drug development.
PD-L1 and predictive tissue biomarkers - In immuno-oncology, one of the most current assays is the determination of PD-L1 status in multiple different tumor types, and most of the current assays that are available are based on IHC. There are also other tissue biomarkers of interest that are influencing combination therapy. By introduction of multiplex IHC, a little amount of tissue can show multiple large numbers of output of markers, and multiple markers can be run in the same tissue sample, in the same assay by the application of multiplex IHC. We are developing multiplex IHC assays that would better define and have a larger output from multiple markers from a small piece of tissue. We support a lot of tissue-based testing where our pathologists clearly identify and earmark the areas of tumor. These samples can be taken for downstream molecular analysis, or for ctDNAs or other sequencing methodologies where our experienced pathologists are able to assure the quality of the sample.
||Our Testing Solutions
|Less Invasive Sampling
- Liquid biopsy: cell free nucleic acids and circulating tumor cells (CTCs)
- Mutation detection including Next Generation Sequencing
- Flow cytometry, immunoassays, proteomics
|Shift toward molecular methods
- Next generation sequencing (NGS) replacing FISH panels
- Gene expression panels replacing multiple IHCs
- Mutation detection at < 0.01%
- Single cell analysis by flow cytometry/molecular platforms
- Detection of disease and early resistance
- Already established for many methods
- Expanding to genomics/NGS platforms
Experience predicting and assessing a patient’s response to checkpoint inhibitors is an integral function to immuno-oncology drug development. Once a tissue sample is received, central tissue pathology testing is performed, and data can be mined for immuno-oncology characterizations, such as PD-L1 proteins or tumor-infiltrating lymphocytes. We then take those characterizations and apply them to drug studies, such as the creation of predictive tissue biomarkers for patient selection.
Digital Pathology: Artificial Intelligence (AI) driven image analysis - Continuously aiming to enable trial sponsors to make smarter decisions throughout the drug development process, Q2 Solutions is focused on digitizing image analysis by leveraging AI-based solutions and automated processes. Helping to extract meaningful data-driven insights, AI-based image analysis provides sponsors with much-needed food for thought to effectively accelerate development and initiate drug discovery.
In a complicated clinical trial landscape with increasing growth in pathology cases, experienced pathologists at Q2 Solutions are using AI to enhance and tailor-fit image analysis processes and solutions to meet the individual needs and goals of each sponsor’s trial program. To optimize its AI-driven approach, the expert team emphasizes the importance of:
- Quality control and quality assurance measures, to ensure consistency and better reproducibility in image analysis results.
- High-resolution images, including three dimensional views, to expand data insights that inform decisions.
- Allowing for remote analysis by pathology experts through comprehensive platform to keep analysis timelines moving efficiently.
- Updating necessary hardware tools, and software tools to analyze multiplex images, spatial arrangement of cells, and content base image retrieval (CBIR) to complement speed and quality provided with AI-solutions for faster and enhanced results.
- Continuously fine-tuning software algorithms to produce better insights, or digital assistance to pathologists to assess morphological features that represent continuum biological processes, such as the Gleason score for prostatic carcinoma and breast cancer grading.
- Allowing faster analysis and higher throughput over time with machine learning capabilities to correlate features related to tumor cell morphology, microenvironment, and invasion to define end points of clinical relevance.
- Expanding breadth of collected data insights per image to leverage for future drug discovery and development needs.
Anatomic Pathology lab partner for your success
Q2 Solutions has the breadth and depth of scientific experience and expertise across all major therapeutic areas, which help drug developers effectively gain a competitive advantage – helping ensure your success in clinical trials, regulatory approvals and new product launches.